Self-inflatable catheter



Sept. 27, 1966 D. A. ROSECRANS SELF-INFLATABLE CATHETER Filed May 22, 1962 INVENTOR.

DEAN A. ROS'ECRANS wii mjmu AT TOFPNEYS United States Patent 3,275,001 SELF-INFLATABLE CATHETER Dean A. Rosecrans, Gardena, Califi, assignor to The Kendall Company, Boston, Mass., a corporation of Massachusetts Filed May 22, 1962, Ser. No. 196,668 Claims. (Cl. 128349) This invention relates to a new and very useful catheter construction. More particularly, this invention relates to an improved (so-called) Foley-type or balloon-type catheter construction having a sterile self-contained inflating means for the retention bag thereof.

Heretofore, when using the conventional Foley-type or balloon type catheter, it was necessary to employ an in dependent and separate sterile bag inflating means. Commonly, a hypodermic syringe was inserted into the filling tube in order to inflate the inflatable bag positioned adjacent the forward end of the catheter tube. Such an external bag filling means is not only inconvenient but frequently endangers patients, owing to the possibility of infection resulting from the use of not properly sterilized inflating equipment. Although the Foley-type catheter has been known in the art for some time, and efiorts have been made to improve upon the same, the present invention represents, so far as known to me, the first commercially useful construction embodying a sterile self-contained inflating means for the retention bag.

To use a conventional Foley catheter, it was necessary for the operator to have cumbersome auxiliary equipment including a sterile needle, a sterile syringe and .a sterile external aqueous fill liquid source. The catheter was first inserted into the body cavity to be drained and the operator inserted the needle into the inflating tube to discharge the liquid fill content of the syringe from the syringe directly into the inflatable bag. Unless the operator was careful, it was very easy to pierce the side wall of the catheter with the sterile needle, and not infrequently puncturing the hand of the operator.

By the present invention, the shortcomings of the prior art Foley-type catheter are circumvented by building into the catheter a self-contained sterile inflating liquid which is introduced into the inflatable bag and near the forward end of the catheter tube when desired by the attendant, by simply manually opening a valve means placed between the fill liquid and the inflatable bag.

More particularly then, this invention relates to a catheter construction comprising an elongated first tube having adjacent to its forward end at least one orifice to permit passage of body fluid into the bore of said tube. Near the forward end of the tube, but rearwards of such orifice or orifices, is placed a resilient distensible wall member which is secured at its ends to engirdle the external portion of the elongated tube. When this resilient distensible wall member is inflated, it forms a bag or balloon. Near the rearward end of the elongated tube is joined an inflating tube. This inflating tube has a seal in its rearward end and has a resilient distensible wall region adjacent such sealed rearward end. This resilient distensible Wall region, when expanded, holds a fill liquid suitable for inflating the inflatable bag formed near the forward end of the elongated tube, as described. The inflating tube and the inflatable bag are connected by a fiHing tube formed in the wall of the elongated first tube between the inflatable bag and the inflating tube.

The whole construction is better understood by reference to the drawings, in which:

FIG. 1 is an elevation, partly sectioned for clarity of illustration, showing the improved Foley-type catheter construction of this invention using one form of internal valve means; a

FIG. 2 is a view in axial section of the construction of "ice FIG. 1 showing a different position of some of the parts thereof;

FIG. 3 is a transverse sectional view taken along the line 33 of FIG. 2 showing the appearance of the internal valve means employed in the embodiment of FIGS. land 2 after such valve means is opened;

FIG. 4 shows an alternate construction for the apparatus of the invention employing an external valve means for controlling flow of fill liquid into the inflatable retention bag; and

FIG. 5 shows a view in elevation, some parts thereof broken away for purposes of illustration, showing an embodiment of the invention employing an alternative form of internal valve means shown in a closed position with the filling bag filled.

As those skilled in the art will appreciate, a Foleytype catheter, as it has been known in the past, is a tubelike medical instrument intended for insertion into'the bladder through the urethra for draining urine therefrom; it is conventionally constructed of latex. As in the conventional Foley catheter, there is presently employed a tube 10 having orifice 11 adjacent it forward end 12 to permit the passage of body fluid into the bore 13 of the tube 10. A resilient distensible wall member 14 is secured at its ends 15 to the exterior of the elongated tube 10. This wall member 14 engirdles the tube 10 over a region slightly behind the orifices 11. A second inflating tube 17 is joined adjacent the rearward region 18 at a point 19. This second inflating tube 17 is fitted with a seal or plug 20 at its rearward end. The expandable wall region 22 when filled with fill liquid can be called the fill bag and such fill bag indicated by the same number, 22.

While any conventional plug means can be employed, I have used the same self-sealing plug as used in conventional so-called Foley-type catheters, wherein when the same is punctured by a hypodermic-type needle and the needle is withdrawn, the plug seals itself. One typeof such plug means is a so-called Gilbert plug.

The rearward region 18 of elongated tube 10 is slightly dilated and consequently has a larger diameter than the remainder of the tube in order to facilitate attachment of drainage tubes, as those skilled in the art will appreciate.

The inflating tube 17 adjacent its sealed rearward end 21 has a resilient distensible wall region 22. This wall region is suitable for holding when expanded a fill liquid 23 adjacent such rearward end.

The inflating tube- 17 is joined to the region of the wall member 14 by means of channel or tube 24. This channel or filling tube 24 is formed in the wall of tube 10 as perhaps can best be seen from the section shown in FIG. 2.

In the embodiment shown in FIGS. 1 and 2, the fill liquid 23 is initially prevented from passing through filling tube 24 and into the bladder region formed by wall member 14 by a simple disk valve means 27. This disk 27 in effect plugs tube 17 until it is manually. displaced. Thus, initially the plug 27 is at right angles to the walls of tube 17 as shown in FIG. 1 and after displacement by simple sidewise rubbing action it occupies a horizontal or parallel position as respects the walls of tube 17, as shown in FIGS. 2 and 3. The construction of the catheter with its inflatable bag before inflation is shown in FIG. 1. Tube 24 opens into a mouth 29 so that fluid passing through tube 24 will fill the region 30 lying between the wall of tube 10 and wall member 14. After the space 30 is filled with fluid 23, the appearance of the inflatable bag is as shown in FIG. 2.

has been used to illustrate the embodiment of the invention in FIGS. 1 and 2, other conventional valve means can 'be'employed. Instead of'using an internal valve means, an external valve means can be employed. One suitable external valve means is shown inFIG. 4. Here, the tube 17 is simply folded back upon itself and the adjacent-lying tube links are constricted together by means of a simple wire wrap 31. Those skilled in the art will appreciate that a conventional laboratory-type tube-clamping means can be employed to const-rict the .wall of the tube behind the filling bag so as to prevent its contents or external valve means should be employed in the interest,

of reliability and operational simplicity.

A preferred internal valve arrangement for the product of this invention employs a latex plug 32 which is bonded with a latex binder 28 to theinternal wall of tube 17 in the region between expandable region 22 and tube 10.-

Enough latex binder is used so as to insure that there will be no leakage or opening of the valve during the;

sterilization and subsequent handling and storage. However, the amount of latex binder or adhesive 28 used is not such as will resist a longitudinal stretching of, the wall 17 in the region of the plug. 7 Hence, when, as by manual pressure, the tube 17 is simply stretched the latex binder 28 breaks or gives way, thereby disrupting the latex plug 32 and permitting liquid to fill the retention bag or wall member 14. V

In openation and use, my catheter 10 is inserted into the urethral tract so that wall member 14 is positioned within the bladder wall 33 and the wall member 14 inflated with liquid by opening the internal or external valve means and allowing the liquid fill in region 22- .to' pass through tube 17 and 24, respectively, and into wall member 14. The tube 10 with the inflated wall member 14 is then drawn tight against the sphincter muscle and the bladder is cleared of urine. To remove the apparatus, the inflating tube 17 is simply punctured or perhaps even sectioned at some point. The resilient wall member 14 compresses the liquid 23 and causes the same to flow back through tube 24 and then through tube 17 to evacuate through the opening just described, thereby collapsing the inflatable bag and permitting the tube 10 to be withdrawn.

Except for the construction of the resilient distensible wall region and the construction of the internal valve means, the apparatus of this invention is made by the usual materials known to those familiar with the art of manufacturing Foley-type catheters.

The resilient distensible wall region 22 of tube 17 is conventionally formed of such a thickness of elastic material (like latex rubber) that the fill liquid is under pressure (at atmospheric pressures). Thus, when the valve means (internal or external) is opened, the fill liquid progresses through the ducts and inflates the wall member 14. The wall member 14 can be constructed of the same material as that used in region 22, but the thickness of wall member 14 is usually much less than that in region 22 so as to insure that sufiicientpressure will be exerted upon the fill liquid 23 in region 22 to force, the same through the ducts when valve members 27,31 or 32 are opened. If the tube is constructed of latex rubber, using the conventionalanode process, I commonly prefer to employ a tube 17 which has been formed by two or 'more clippings and to have a Wall member 14 formed by a single dip; Those skilled inthe art will, however,

struction of my invention is to bemade by any one process of manufacture. In general, however, for purposes of slightly more elastic than the retention bag when the valve means on or in tube 17 is removed or opened.

Any conventional sterilization and fill bag filling procedures can be employed, as those skilled in the art will appreciate.

The fill liquid introduced into the fill bag is of controlled volume and maintains such volume afterlrelease of the valve means, such as the'internal valve means shown in FIG. 5, in order to insurea controlled filling of the inflatable bag. Preferably, the fill liquid is aqueous.

While the foregoing description has been restricted chiefly to improved Foley-type catheter constructions of the type shown in the figures, it will be appreciated that the inflating second tube 17,in general,'need only be coextensive with said first tube 10. Thus,-said second tube could extend interiorly of said first tube to connect the distensible wall region of the first tube with the filling bag Similarly, the inflating second tube could besimply a small exterior structure generally mounted .on the outside I of I the elongated first tube between. the interior of the distensible wallregion of the first; tube and. 'the filling bag. 'It is thus visualized thatsaid-second tube could comprise a tube structure between the inflatable bag region 14 and the rearward end of tube region 17, which is generally coextensive with the first-tube between its forward end 12 and rearward thereof to a distance sufiicient to dispose end tube region 17 outside of the.

body cavity. It appears desirable that rearward end tube portion 17 be spaced from the first tube 10. i I

My invention has been made and tested and in suitable commercial forms has indeed proven to be of consider able commercial significance. While I have shown and described preferred forms of my invention, modifications thereof might be made by those skilled in the art all within the scope of my invention, and I intend to be. .limited solelyby the scope of the appended claims.

tube-like means and forming an inflatable retaining bag positioned rear'wardly spaced from but adjacent said orifice;

(d) a second resilient distensible Wall member movable between an expanded stressed position and a contracted position and which defines a fluid reservoir rea'rwardly spaced from said retaining bag.

and constructed to contain a fill liquid;

(c) said filling passage communicating with said inflatable bag and connected to said second distensible wall member;

(f) said second resilient distensible wall member being closed except for said connection between said filling passage and said second distensible wall member;

(g) releasable closure means positioned to close communication between said reservoir and said in-flatable bag until released;-j

(h) a fill liquid in said reservoir expanding said second resilient distensiblel.wall member thereby creating stresses therein opposing expansion which if unopposed would contractisaid second resilient dis- 1 tensi'ble wall member and which places {said fill 1 j liquid under pressure from said secondresilient dis-.1

tensible wall member; and

(i) the resilient distensible wall member forming said inflatable retaining bag being inflatable at a lower internal fluid pressure than the pressure on said fill liquid in said reservoir so that when said re-' leasable closure means is released, fill liquid will pass into and inflate said inflatable retaining bag.

2. The structure of claim 1 in which said releasable closure means comprises an external clamp engaging wall portions defining said filling passage at a point between said fluid reservoir and said inflatable bag and said clamp compressing said wall portions and closing said filling pass-age until released.

3. The structure of claim 1 in which said releasable closure means comprises an internal plug releasably secured in said filling passage between said reservoir and said inflatable bag and closing said filling passage until released.

4. A catheter construction comprising:

(a) an integral elongated tube member bifurcated adjacent its rearward end to provide an elongated first tube portion and a second tube portion connected to the first tube portion adjacent the rearward end thereof;

(b) said first tube portion formed to provide a pair of separate generally coextensive adjacent passages forwardly of said second tube portion one being a body fluid discharge passage and the other being a retaining bag filling passage and to provide rear- Wardly of said second tube portion a draining tube portion defining the rearward end region of said body fluid discharge passage;

(c) said second tube portion having a penetrable resealable seal adjacent its rearward end and communicating with said retaining bag filling passage;

((1) an external releasable clamp member connected to said second tube portion;

(e) said first tube portion having adjacent its forward end an orifice to permit the flow of body fluid into said body-fluid discharge passage;

(f) a resilient distensible wall member secured to said first tube portion rearwardly spaced from but adjacent said orifice and forming an inflatable retaining bag positioned adjacent said orifice, said filling passage communicating with said inflatable retaining bag;

(g) said second tube portion between said seal and said clamp member being resilient and distensible and movable between an expanded stressed position and a contracted position and constructed to contain a -fill liquid to define a fluid reservoir rearwardly spaced from said retaining bag;

(h) an aqueous fill liquid in said reservoir expanding said second tube member thereby creating stresses therein opposing expansion which if unopposed would contract said sec-ond tube member and which places said fill liquid under pressure from said second tube portion;

(i) said clamp member closing communication between said reservoir and said retaining bag through said filling passage until released;

(1') said inflatable retaining bag being inflatable at a lower internal pressure than the pressure on said fill liquid in said reservoir so that when said clamp member is released, fill liquid will pass through said filling passage into and inflate said inflatable retaining bag; and

('k) said second tube portion upon release of said clamp member moving to a contracted position and maintaining the same against the pressure of fill liquid in said inflatable retaining bag to retain the fill liquid in said retaining bag for normal periods of time; and whereby said catheter may be retained by the inflation of said bag in a body cavity for normal periods of time until the fillliquid is removed from the inflatable retaining bag by any suitable means.

5. The structure of claim 4 in which the thickness of the walls of the resilient distensible wall member is less than the thickness of the walls of said second tube member.

References Cited by the Examiner UNITED STATES PATENTS 868,450 10/ 1907 Kistler 128-246 2,026,747 1/ 1936 Nemzek 128344 2,854,982. 10/ 1958 Pagano 128348 3,044,468 7/1962 Birtwell 128--349 FOREIGN PATENTS 43 9,636 4/ 1912 France. 3 28,889 1/ 1903 France.

ROBERT E. MORGAN, Acting Primary Examiner. JORDAN FRANKLIN, Examiner.

D. L. TRULUCK, Assistant Examiner. 

1. A CATHETER CONSTRUCTION COMPRISING: (A) ELONGATED TUBE-LIKE MEANS DEFINING A PAIR OF LONGITUDINALLY EXTENDING PASSAGES, ONE OF SAID PASSAGES BEING A BODY FLUID DISCHARGE PASSAGE AND THE OTHER BEING A RETAINING BAG FILLING PASSAGE; (B) SAID MEANS HAVING ADJACENT ITS FORWARD END AT LEAST ONE ORIFICE FORMED IN SAID DISCHARGE PASSAGE TO PERMIT THE FLOW OF BODY FLUID INTO SAID DISCHARGE PASSAGE; (C) A RESILIENT DISTENSIBLE WALL MEMBER ATTACHED TO SAID TUBE-LIKE MEANS AND FORMING AN INFLATABLE RETAINING BAG POSITIONED REARWARDLY SPACED FROM BUT ADJACENT SAID ORIFICE; (D) A SECOND RESILIENT DISTENSIBLE WALL MEMBER MOVABLE BETWEEN AN EXPANDED STRESSED POSITION AND A CONTRACTED POSITION AND WHICH DEFINES A FLUID RESERVOIR REARWARDLY SPACED FROM SAID RETAINING BAG AND CONSTRUCTED TO CONTAIN A FILL LIQUID; (E) SAID FILLING PASSAGE COMMUNICATING WITH SAID INFLATABLE BAG AND CONNECTED TO SAID SECOND DISTENSIBLE WALL MEMBER; (F) SAID SECOND RESILIENT DISTENSIBLE WALL MEMBER BEING CLOSED EXCEPT FOR SAID CONNECTION BETWEEN SAID FILLING PASSAGE AND SAID SECOND DISTENSIBLE WALL MEMBER; (G) RELEASABLE CLOSURE MEANS POSITIONED TO CLOSE COM- 